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In fact, prescription drugs accounted for $328.6 billion of national health-related spending in the United States in 2016.(1) According to the Centers for Disease Control and Prevention (CDC), “In 2015–2016, 45.8% of the U.S. population used prescription drugs in the past 30 days.”(2)
New drugs can bring new risks for people who take them. Adverse drug events (ADEs) can lead to serious medical complications or death.
In July 2018, a 9-year study (2006 to 2014) of the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System database found 902,323 serious outcomes were reported to the FDA, including 244,408 deaths and 72,141 disabilities. (3)
New drugs must be approved by the FDA before they are sold. However, problems may still occur at any time — before, during, or after the approval process. In fact, many FDA-approved drugs have been linked with serious medical complications.
This is because drugs are tested only in a limited number of studies before being approved for the market. For this reason, it is important for patients and physicians to report drug adverse event to the FDA when such occur.
If you suffered severe complications or were hospitalized due to an adverse drug event, or if a relative died due to prescription drug-related complications, you may want to discuss your legal options with a knowledgeable attorney.
Weitz & Luxenberg may be able to help. We invite you to call us for a free consultation (855) 274-5624.
Consult your doctor before stopping any prescribed medication.
How Are Drugs Approved?
In 1938, Congress enacted the Food, Drug, and Cosmetic (FDC) Act. Since then, the drug approval process has continued to evolve.
In 1962, a sleeping pill called thalidomide, not approved for use in the U.S. due to efforts taken by Dr. Frances Kelsey at the FDA, resulted in thousands of babies being born with birth defects in Western Europe after their mothers had taken the drug during pregnancy. In response, Congress approved legislation requiring drug manufacturers to demonstrate to the FDA that any new drug is safe and effective for its intended use before selling it in the U.S.(4)
To secure FDA approval, drug manufacturers must conduct limited laboratory, animal, and clinical tests to determine how new drugs work and whether they are safe for use in humans.
A team at the FDA’s Center for Drug Evaluation and Research (CDER) composed of doctors, chemists, and other scientists reviews the evidence from these limited tests. If this group of FDA employees determines results presented from this testing demonstrate a level of safety and a measurable health benefit, the FDA may approve the drug.(5) In some cases, especially for particular classes of drugs, the FDA may approve a drug with the stipulation that additional postmarketing testing be conducted or that postmarketing safety monitoring of particular adverse events be performed by the manufacturer.(6) (7)
Potential Risks from New Drugs
Sometimes the tests do not reveal all the potential risks of a new drug. In addition, in some cases, drug manufacturers fail to present all their evidence, submit erroneous or falsified information, fail to report adverse events or other study protocol violations, or fail to protect the safety of clinical trial patients.(8)
In addition, drug manufacturers may not communicate the risks of a drug to the public, even if the FDA discovers a problem at a clinical trial site during an inspection or after a medical journal publishes the results of a clinical trial. In fact, sometimes the problems can be substantial enough to cause or contribute to serious medical complications or even death.
Somewhere down the line, the FDA may require updated label instructions or warnings for complications, but, by then, the damage may have already been done. For some patients, the warning may come too late.
Adverse effects of medicines have spawned thousands of lawsuits in recent years.
Belviq and Belviq XR are weight management medications approved to help treat adults with weight-related conditions. However, the FDA has warned the public regarding an increased occurrence of cancer in a clinical trial in patients taking Belviq.(9) (10)
Because of this, the agency asked the manufacturer to withdraw these drugs from the U.S. market in February 2020, and they are no longer available for use in the United States.(11)
Belviq and Belviq XR are two formulations of the drug lorcaserin. They are “satiety promoters.” Satiety promoters are intended to help people feel less hungry.(12)
In 2012, the FDA approved Belviq for use in helping adult patients with particular weight-related conditions control their weight. (13) These conditions include (14):
- Adults who are obese, with a body mass index (BMI) of 30 kg/m2 or greater.
- Adults who are overweight with an initial body mass index of 27 kg/m2 or greater who also are diagnosed with one weight-related comorbid condition (such as hypertension or type 2 diabetes).
Patients prescribed Belviq were also supposed to adhere to a reduced-calorie diet, as well as engage in more physical activity. (15)
Belviq XR is a once-daily version of Belviq. The FDA approved this formulation of lorcaserin in 2016. (16)
When the FDA initially approved Belviq, the FDA instructed its manufacturer to conduct a study about the drug’s possible cardiovascular risks. (17)
What emerged from that clinical study was an alarming pattern linking lorcaserin to an increased number of patients diagnosed with cancer. Patients who received lorcaserin showed an increased occurrence of cancer overall, and especially: (18)
- Pancreatic cancer.
- Colorectal cancer.
- Lung cancer.
Common side effects for non-diabetic patients taking Belviq and Belviq XR include, but are not limited to: (19) (20)
- Dry mouth.
Common side effects for patients with diabetes who are taking Belviq and Belviq XR include, but are not limited to:
- Back pain.
Belviq and Belviq XR labeling contains warnings regarding:
- Serotonin syndrome or neuroleptic malignant syndrome-like reactions.
- Valvular heart disease.
- Cognitive impairment, including impairments in attention and memory.
- Psychiatric disorders, including euphoria, hallucinations, and dissociation.
- Hypoglycemia in patients with type 2 diabetes on anti-diabetic drugs.
- Heart rate decreases.
- Hematological changes, including leukopenia, lymphopenia, neutropenia, and decreased white blood cell counts.
- Prolactin elevation.
- Pulmonary hypertension.
Elmiron (Pentosan Polysulfate Sodium)
Elmiron (pentosan polysulfate sodium) is approved by the FDA to treat interstitial cystitis. (21)
Interstitial cystitis is a chronic, regional pain syndrome affecting the bladder and pelvis. Nationwide, over 1 million people are estimated to have this condition. (22)
Interstitial cystitis is diagnosed in women more often than men. Symptoms may include urinary urgency, frequent urination, chronic pelvic pain, and painful sexual intercourse. (23)
In recent years, alarming reports about Elmiron eye- and vision-related adverse events have emerged. Pentosan polysulfate sodium may lead to a specific type of vision loss known as pigmentary maculopathy. (24) (25)
Elmiron may damage a person’s retina, especially the central portion, known as the macula. A healthy, intact retina is critical for helping people to see clearly and accurately, and the macula is essential to see details of near objects. (26)
Recent studies link longer-term use of Elmiron to a specific type of retinal eye damage. This condition is called pigmentary maculopathy. (27) (28) (29)
Symptoms of pigmentary maculopathy may include: (30) (31)
- Blurred vision.
- Difficulty reading.
- Prolonged dark adaptation.
Metamorphopsia is a specific kind of perceptual distortion where linear objects appear curved or discontinuous. (32)
Elmiron eye damage complications are thus far believed to be irreversible. (33)
Patients taking Elmiron who develop drug-induced pigmentary maculopathy may be misdiagnosed as having pattern dystrophy or macular degeneration. (34)
Provigil and Nuvigil
Provigil (modafinil) or Nuvigil (armodafinil) may be prescribed for patients who suffer from excessive sleepiness due to obstructive sleep apnea, narcolepsy, or “shift work disorder.”
In women who took these drugs while pregnant, Provigil and Nuvigil have been linked with birth defects and spontaneous abortions. (35) (36)
These serious birth defect side effects for Provigil and Nuvigil include: (37) (38)
- Congenital heart defects.
- Cleft lip or palate (orofacial clefts).
Canadian regulators have issued an alert to their health care professionals based on results from the FDA Nuvigil/Provigil Pregnancy Registry. (39)
The Canadian government indicates that the birth defects from taking modafinil include congenital cardiac abnormalities and “other adverse reactions.” Canada is advising health care providers to discuss the pregnancy risks of taking modafinil with female patients.(40)
The Canadian safety alert says children have suffered major congenital birth defects, including heart defects and microcephaly, due to exposure to Provigil or Nuvigil, while they were in utero. (41)
Provigil and Nuvigil are both manufactured by Cephalon, Inc. which is a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. Provigil received FDA approval in 1998, and Nuvigil was approved in 2007. (42) (43)
Teva Ireland issued a Direct Healthcare Professional Communication in agreement with the European Medicines Agency and Health Products Regulatory Authority. It stated that using modafinil during pregnancy is suspected to cause congenital malformations, based on post-marketing reports, and as such should not be used during pregnancy. The Communication also stated women who can become pregnant must use effective contraception during and for two months after stopping using modafinil. (44) (45)
Types of congenital heart defects include, among many others:
- Atrial septal defects.
- Atrioventricular septal defects.
- Coarctation of the aorta.
- Double-outlet right ventricle.
- D-transposition of the great arteries.
- Ebstein anomaly.
- Hypoplastic left heart syndrome.
- Interrupted aortic arch.
- Pulmonary atresia.
- Single ventricle.
- Tetralogy of Fallot.
- Total anomalous pulmonary venous return.
- Tricuspid atresia.
- Truncus arteriosus.
- Ventricular septal defects.
How Weitz & Luxenberg Can Help
For more than 30 years, Weitz & Luxenberg has been at the forefront of complex product liability-related litigation. Our attorneys have secured more than $17 billion in awards and settlements for clients.
Although past results are no guarantee of future success, Weitz & Luxenberg possesses the experience and resources necessary to pursue justice for clients harmed by the negligence of large drug companies.
If you have been injured by a defective drug, we can help you understand your legal options, beginning with a free consultation. Call us at (855) 274-5624 or fill out the form on this page. One of our representatives will be in touch with you shortly.